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This decision is not that surprising, says James Boiani, a member of the firm Epstein Becker Green’s Washington, D.C., office.

“In July of this year, the FDA presented the Rexista application to FDA advisory committees which concluded by a wide margin that abuse deterrence claims made in the application had not been proven,” Boiani says. “More broadly, though, what is happening is that the FDA and committee members are strictly scrutinizing claims about abuse deterrence in response to the opioid crisis and, I think, lingering concerns that the addictiveness of previously approved opioids was not adequately communicated to physicians or patients. No one wants a product coming out with implied promises of preventing abuse that gives a bump to opioid prescribing without knowing with certainty that it will actually help deter abuse.”